Before the effective data of HIPAA, April 14, 2003 at the earliest, the privacy of
medical information was controlled the state and federal laws discussed earlier
in this section, which provided relatively limited protections. Research data
was protected by the federal regulation called the Common Rule. To a great
extent, the Common Rule, and the related FDA regulations on human subjects
research, left the questions about access to patient information and protection
of that data to IRBs. Authorization to release information, how that information
would be used and protected, and whether authorization was needed at all,
was considered part of the informed consent process. HIPAA recognized that
there would be situations where the its general requirement of specific
authorization for the release of PHI would be difficult in some research
settings. The most obvious examples were all of the research that was begun
before the effective data of HIPAA and was still going on. This included multi-
year community studies with datasets going back for decades. Strict
application of HIPAA would require getting new authorizations from every
study participant.